NCT06534983

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)

A Randomized Phase II, Double-blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-risk Muscle-invasive Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

Conditions

• Muscle-invasive Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Autogene Cevumeran	Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
DRUG	Nivolumab	Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
DRUG	Saline	Saline solution for IV infusion.

Timeline

• Start date: 2024-12-09
• Primary completion: 2027-11-10
• Completion: 2027-11-10
• First posted: 2024-08-02
• Last updated: 2026-04-09

Locations

107 sites across 20 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study